U.S. patent application number 14/754085 was filed with the patent office on 2015-11-05 for thermoformed ophthalmic insert devices.
This patent application is currently assigned to Johnson & Johnson Vision Care, Inc.. The applicant listed for this patent is Johnson & Johnson Vision Care, Inc.. Invention is credited to Frederick A. Flitsch, Camille Higham, Edward R. Kernick, Douglas Lilac, Randall B. Pugh, Karson S. Putt, Sharika Snook.
Application Number | 20150316789 14/754085 |
Document ID | / |
Family ID | 50343622 |
Filed Date | 2015-11-05 |
United States Patent
Application |
20150316789 |
Kind Code |
A1 |
Pugh; Randall B. ; et
al. |
November 5, 2015 |
THERMOFORMED OPHTHALMIC INSERT DEVICES
Abstract
The present invention describes single-piece or multi-piece
Rigid Inserts that may be included in an Ophthalmic Lenses or may
comprise the Ophthalmic Lens, wherein the Rigid Insert may be
formed through the processing of thin sheet material by
thermoforming. Single piece annular Rigid Inserts may perform the
function of providing a template for printed patterns to be
included in Ophthalmic Lenses. Single piece full Rigid Inserts may
perform the function of polarizing light or filtering light based
on the properties of materials used to form the insert. Multi-piece
Rigid Inserts may include activation and energization elements. The
present invention also includes methods and apparatus for forming
the Rigid Inserts.
Inventors: |
Pugh; Randall B.;
(Jacksonville, FL) ; Putt; Karson S.;
(Jacksonville, FL) ; Kernick; Edward R.;
(Jacksonville, FL) ; Lilac; Douglas; (Saint Johns,
FL) ; Flitsch; Frederick A.; (New Windsor, NY)
; Higham; Camille; (Jacksonville, FL) ; Snook;
Sharika; (St. Augustine, FL) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Johnson & Johnson Vision Care, Inc. |
Jacksonville |
FL |
US |
|
|
Assignee: |
Johnson & Johnson Vision Care,
Inc.
Jacksonville
FL
|
Family ID: |
50343622 |
Appl. No.: |
14/754085 |
Filed: |
June 29, 2015 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
13832547 |
Mar 15, 2013 |
9069186 |
|
|
14754085 |
|
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Current U.S.
Class: |
351/159.03 ;
351/159.02; 351/159.11; 351/159.24 |
Current CPC
Class: |
B29D 11/00009 20130101;
G02C 7/083 20130101; G02C 7/046 20130101; G02C 7/049 20130101; G02C
7/04 20130101; G02C 7/022 20130101; B29D 11/00817 20130101; G02C
7/044 20130101 |
International
Class: |
G02C 7/04 20060101
G02C007/04; G02C 7/08 20060101 G02C007/08 |
Claims
1. An ophthalmic lens comprising an insert device, the insert
device comprising: a first insert piece formed of a thermoformed
material having a three-dimensional shape; and a hydrogel
encapsulant around the insert device.
2. The ophthalmic lens of claim 1, wherein the insert device
further comprises an alignment feature.
3. The ophthalmic lens of claim 1, wherein the first insert piece
further comprises: an optic zone, wherein the thermoformed material
in at least the optic zone has the ability to polarize light that
traverses the optic zone.
4. The ophthalmic lens of claim 1, wherein the insert device
comprises a plurality of layers of material.
5. The ophthalmic lens of claim 4, wherein a first layer of
material has dielectric properties and encloses a portion of a
conductive material located upon a surface of the first insert
piece.
6. The ophthalmic lens of claim 4, wherein a first layer of
material has insulating properties and encloses a portion of a
conductive material located upon a surface of the first insert
piece.
7. The ophthalmic lens of claim 4, further comprising a layer of
colorant covering a portion of the first insert piece.
8. The ophthalmic lens of claim 4, additionally comprising: a
second layer adjacent to a first layer, and a polarizing layer
between the second layer and a third layer, wherein the second and
third layer orient the polarizing layer.
9. The ophthalmic lens of claim 1, wherein the insert device has an
annular shape.
10. The ophthalmic lens of claim 9, wherein the insert device
additionally comprises a layer of colorant that covers at least a
portion of the annular shaped insert device.
11. The ophthalmic lens of claim 10, wherein the layer of colorant
comprises an iris pattern.
12. The of claim 1, wherein the insert device includes an active
agent.
13. The ophthalmic lens of claim 1 additionally comprising: a
stabilizing feature capable of orienting the ophthalmic lens in a
predefined orientation on an eye, wherein the stabilizing feature
comprises a tint that provides a visual orientation cue.
14. The ophthalmic lens of claim 1 wherein the insert device is a
thermoformed insert device.
15. The ophthalmic lens of claim 1 wherein the insert device
further comprises a second insert piece formed of a thermoformed
material having a three-dimensional shape.
16. The ophthalmic lens of claim 15, wherein the first insert piece
and the second insert piece are of different sizes.
17. The ophthalmic lens of claim 15, wherein alignment features on
the first insert piece are fit to alignment features on the second
insert piece.
18. The ophthalmic lens of claim 15, wherein the first insert piece
and second insert piece, when fit together, are configured to hold
a lenslet.
19. The ophthalmic lens of claim 1, wherein the three-dimensional
shape of the first insert piece comprises at least two distinct
regions of differing curvature.
20. The ophthalmic lens of claim 19, wherein the three-dimensional
shape of the first insert piece comprises at least one convex
region and at least one concave region.
21. The ophthalmic lens of claim 19, wherein the insert device
further comprises a second insert piece formed of a thermoformed
material having a three-dimensional shape.
22. The ophthalmic lens of claim 21, wherein the three-dimensional
shape of the second insert piece comprises a curved region having a
curvature different from at least one region of the first insert
piece.
23. The ophthalmic lens of claim 22, wherein the three-dimensional
shape of the second insert piece comprises multiple distinct curved
regions of differing curvature.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] The present application is a continuation of U.S. patent
application Ser. No. 13/832,547, filed Mar. 15, 2013 (now allowed),
the contents of which is incorporated by reference in its
entirety.
FIELD OF USE
[0002] This invention describes methods, apparatus and devices
related to thermoforming of insert pieces for inclusion into other
Ophthalmic Devices and more specifically, in some embodiments,
manners of using thermoforming aspects in the fabrication of an
Ophthalmic Lens with a Rigid Insert within which or upon which are
components.
BACKGROUND
[0003] Traditionally an Ophthalmic Device, such as a contact lens,
an intraocular lens, or a punctal plug included a biocompatible
device with a corrective, cosmetic, or therapeutic quality. A
contact lens, for example, can provide one or more of
vision-correcting functionality, cosmetic enhancement, and
therapeutic effects. Each function is provided by a physical
characteristic of the lens. A design incorporating a refractive
quality into a lens can provide a vision corrective function. A
pigment incorporated into the lens can provide a cosmetic
enhancement. An active agent incorporated into a lens can provide a
therapeutic functionality. Such physical characteristics may be
accomplished without the lens entering into an energized state.
[0004] More recently, active components have been incorporated into
a contact lens.
[0005] An alternative solution may involve the incorporation of
energizing elements within the Ophthalmic Device. The relatively
complicated components to accomplish this effect may derive
improved characteristics by including them in insert devices, which
are then included with standard or similar materials useful in the
fabrication of state of the art Ophthalmic Lenses. It may be
desirable to improve the process, methods, and resulting devices
for realizing inserts of various kinds. It may be anticipated that
some of the solutions for energized inserts may provide novel
aspects for non-energized devices and other biomedical devices.
Accordingly novel methods, devices, and apparatus relating to the
thermoforming of various components in ophthalmic and biomedical
devices formed with inserts are therefore important.
SUMMARY
[0006] The present invention includes innovations relating to the
method of forming Ophthalmic Lens with a thermoformed insert
device, the Ophthalmic Lens comprising a thermoformed insert
device, wherein the thermoformed insert device comprises a first
insert piece, wherein the first insert piece is a thermoformed
material of a three-dimensional shape, and a hydrogel encapsulant
around the thermoformed insert device.
[0007] In some embodiments, the thermoformed insert device may
further comprise an alignment feature. In some embodiments, the
thermoformed insert device may further comprise an optic zone,
wherein the thermoformed material in at least the optic zone has
the ability to polarize light that traverses the optic zone.
Alternatively, the thermoformed insert may be annular, wherein a
circular portion in the center of the thermoformed insert may be
removed during the thermoforming process.
[0008] The thermoformed insert device may comprise a plurality of
layers of material. A first layer of material may have dielectric
properties and encloses a portion of a conductive material located
upon a surface of the insert piece. The first layer of material may
have insulating properties and enclose a portion of a conductive
material located upon a surface of the insert piece. In some
embodiments, a layer of material may alter the hydrophobicity of
the surface of the insert piece.
[0009] Some such embodiments may include a layer of colorant
covering a portion of the insert piece, for example, in an iris
pattern. A polarizing layer may be located between a second and
third layer, which may be adjacent to the first layer, and wherein
the second and third layer may orient the polarizing layer. The
polarizing layer may be aligned with respect to the alignment
feature located within the body of the first insert piece. In such
embodiments, the Ophthalmic Lens may additionally comprising a
stabilizing feature included in the Ophthalmic Lens device, wherein
the stabilizing feature orients the lens device in a predefined
orientation on an eye. The Stabilizing Feature may be tinted or
marked to provide a visual orientation cue, wherein the Stabilizing
Feature may indicate to the user how to orient the Ophthalmic Lens
on the eye.
[0010] In some embodiments, the thermoformed insert device may
comprise a second insert piece, wherein the second insert piece is
a thermoformed material of a three-dimensional shape, wherein a
cavity is defined in a region between the first insert piece and
the second insert piece. The thermoformed insert device may further
comprise a first alignment feature located on the first insert
piece and a second alignment feature located on the second insert
piece. The first alignment feature may interlock with the second
alignment feature. The thermoformed insert device may further
comprise a sealing layer between the first insert piece and second
insert piece that seals the first insert piece and second insert
piece together along at least portions of their surfaces.
[0011] In some embodiments, the thermoformed insert device further
may comprise a meniscus lens active optic element, wherein the
meniscus lens active optic element is located between the first
insert piece and the second insert piece. Alternatively, the
thermoformed insert device may include an active agent, wherein the
active agent may dissolve into the ophthalmic environment when the
Ophthalmic Lens is placed on an eye.
DESCRIPTION OF THE DRAWINGS
[0012] FIG. 1 illustrates an exemplary thermoforming apparatus
according to some embodiments of the present invention.
[0013] FIG. 2 illustrates exemplary processing steps to thermoform
a component consistent with an active energized Ophthalmic
Lens.
[0014] FIG. 3 illustrates an exemplary complex insert piece that
may be thermoformed according to some embodiments of the present
invention.
[0015] FIG. 4 illustrates exemplary alignment features and
strategies that may be incorporated into inserts utilizing the
principles of thermoforming.
[0016] FIG. 5 illustrates an exemplary Rigid Insert embodiment
utilizing the principles of thermoforming.
[0017] FIG. 6 illustrates an exemplary Media Insert embodiment
utilizing the principles of thermoforming.
[0018] FIG. 7 illustrates an exemplary lenslet based embodiment
utilizing the principles of thermoforming.
[0019] FIG. 8 illustrates exemplary functional features and
strategies that may be incorporated in inserts utilizing the
principles of thermoforming.
[0020] FIG. 9 illustrates an exemplary aligned differential
polarization element embodiment for Ophthalmic Lenses utilizing the
principle of thermoforming.
[0021] FIG. 10 illustrates a processing flow in an exemplary method
to form thermoformed components and Ophthalmic Lenses incorporating
them.
DETAILED DESCRIPTION OF THE INVENTION
[0022] The present invention includes methods and apparatus for
manufacturing an Ophthalmic Lens with a Rigid Insert where portions
of the insert may be formed by the method of thermoforming. In
addition, the present invention includes an Ophthalmic Lens with a
Rigid Insert incorporated into the Ophthalmic Lens.
[0023] According to the present invention, an Ophthalmic Lens may
be formed with an embedded Insert, which in some cases includes an
Energy Source, such as an electrochemical cell or battery as the
storage means for the energy. In some embodiments, a Rigid Insert
also includes a pattern of circuitry, components, and Energy
Sources. Various embodiments may include the Rigid Insert locating
the pattern of circuitry, components, and Energy Sources around a
periphery of an optic zone through which a wearer of a lens would
see, while other embodiments may include a pattern of circuitry,
components, and Energy Sources that are small enough to not
adversely affect the sight of a contact lens wearer and therefore
the Rigid Insert can locate them within, or exterior to, an optical
zone. The insert pieces of single-piece and multi-piece Rigid
Inserts may be formed by thermoforming Numerous steps may occur on
a thin substrate sheet before thermoforming or on an insert piece
after thermoforming that may address the various component
functions of insert-based Ophthalmic Devices.
[0024] In general, according to some embodiments of the present
invention, a Rigid Insert may be embodied within an Ophthalmic Lens
via automation that may place the insert a desired location
relative to a mold part used to fashion the lens. The embodiments
that place the various components into the Ophthalmic Lens may
employ one or more steps where components are sealed and adhered
into place or components are encapsulated.
[0025] In some embodiments, an Energy Source may be placed in
electrical communication with a component that can be activated on
command and draws electrical current from the Energy Source
included within the Ophthalmic Lens. A component may include, for
example, a semiconductor device, an active or passive electrical
device, or an electrically activated machine, including for
example: Microelectromechanical systems (MEMS),
nanoelectromechanical systems (NEMS), or micromachines. Subsequent
to placing the Energy Source and component, a Reactive Mixture can
be shaped by the mold part and polymerized to form the Ophthalmic
Lens.
[0026] In the following sections detailed descriptions of
embodiments of the invention will be given. The description of both
preferred and alternative embodiments are exemplary embodiments
only, and it is understood that to those skilled in the art that
variations, modifications, and alterations may be apparent. It is
therefore to be understood that said exemplary embodiments do not
limit the scope of the underlying invention.
GLOSSARY
[0027] In this description and claims directed to the presented
invention, various terms may be used for which the following
definitions will apply:
[0028] Back Curve Piece or Back Insert Piece: as used herein refers
to a solid element of a Rigid Insert which when assembled into the
said insert will occupy a location on the side of the lens that is
on the back. In an Ophthalmic Device, such a piece would be located
on the side of the insert that would be closer to the user's eye
surface. In some embodiments, the back curve piece may contain and
include a region in the center of an Ophthalmic Device through
which light may proceed into the user's eye, which may be called an
Optic Zone. In other embodiments, the piece may take an annular
shape where it does not contain or include some or all of the
regions in an optic zone. In some embodiments of an ophthalmic
insert, there may be multiple back curve pieces and one of them may
include the optic zone, while others may be annular or portions of
an annulus.
[0029] Component: as used herein refers to a device capable of
drawing electrical current from an Energy Source to perform one or
more of a change of logical state or physical state.
[0030] Encapsulate: as used herein refers to creating a barrier to
separate an entity, such as, for example, a Media Insert, from an
environment adjacent to the entity.
[0031] Encapsulant: as used herein refers to a layer formed
surrounding an entity, such as, for example, a Media Insert, that
creates a barrier to separate the entity from an environment
adjacent to the entity. For example, Encapsulants may be comprised
of silicone hydrogels, such as Etafilcon, Galyfilcon, Narafilcon,
and Senofilcon, or other hydrogel contact lens material. In some
embodiments, an Encapsulant may be semipermeable to contain
specified substances within the entity and preventing specified
substances, such as, for example, water, from entering the
entity.
[0032] Energized: as used herein refers to the state of being able
to supply electrical current to or to have electrical energy stored
within.
[0033] Energy: as used herein refers to the capacity of a physical
system to do work. Many uses within this invention may relate to
the said capacity being able to perform electrical actions in doing
work.
[0034] Energy Source: as used herein refers to device capable of
supplying Energy or placing a biomedical device in an Energized
state.
[0035] Energy Harvesters: as used herein refers to device capable
of extracting energy from the environment and convert it to
electrical energy.
[0036] Front Curve Piece or Front Insert Piece: as used herein
refers to a solid element of a Rigid Insert, which when assembled
into the said insert will occupy a location on the side of the lens
that is on the front. In an Ophthalmic Device, a Front Curve Piece
would be located on the side of the insert that would be further
from the user's eye surface. In some embodiments, the piece may
contain and include a region in the center of an Ophthalmic Device
through which light may proceed into the user's eye, which may be
called an Optic Zone. In other embodiments, the piece may take an
annular shape where it does not contain or include some or all of
the regions in an optic zone. In some embodiments of an ophthalmic
insert, there may be multiple front curve pieces and one of them
may include the optic zone, while others may be annular or portions
of an annulus.
[0037] Lens-forming mixture or Reactive Mixture or Reactive Monomer
Mixture (RMM): as used herein refers to a monomer or prepolymer
material that can be cured and cross-linked or cross-linked to form
an Ophthalmic Lens. Various embodiments can include lens-forming
mixtures with one or more additives such as UV blockers, tints,
photoinitiators or catalysts, and other additives one might desire
in an Ophthalmic Lenses such as, contact or intraocular lenses.
[0038] Lens-forming Surface: refers to a surface that is used to
mold a lens. In some embodiments, any such surface can have an
optical quality surface finish, which indicates that it is
sufficiently smooth and formed so that a lens surface fashioned by
the polymerization of a lens forming material in contact with the
molding surface is optically acceptable. Further, in some
embodiments, the lens forming surface can have a geometry that is
necessary to impart to the lens surface the desired optical
characteristics, including without limitation, spherical,
aspherical and cylinder power, wave front aberration correction,
corneal topography correction and the like as well as any
combinations thereof.
[0039] Lithium Ion Cell: refers to an electrochemical cell where
Lithium ions move through the cell to generate electrical energy.
This electrochemical cell, typically called a battery, may be
reenergized or recharged in its typical forms.
[0040] Media Insert: as used herein refers to an encapsulated
insert that will be included in an energized Ophthalmic Device. The
energization elements and circuitry may be embedded in the Media
Insert. The Media Insert defines the primary purpose of the
energized Ophthalmic Device. For example, in embodiments where the
energized Ophthalmic Device allows the user to adjust the optic
power, the Media Insert may include energization elements that
control a liquid meniscus portion in the Optical Zone.
Alternatively, a Media Insert may be annular so that the Optical
Zone is void of material. In such embodiments, the energized
function of the Lens may not be optic quality but may be, for
example, monitoring glucose or administering medicine.
[0041] Mold: refers to a rigid or semi-rigid object that may be
used to form lenses from uncured formulations. Some preferred molds
include two mold parts forming a front curve Mold part and a back
curve Mold part.
[0042] Ophthalmic Lens or Ophthalmic Device or Lens: as used herein
refers to any device that resides in or on the eye. The device may
provide optical correction, may be cosmetic, or provide some
functionality unrelated to optic quality. For example, the term
Lens may refer to a contact Lens, intraocular Lens, overlay Lens,
ocular insert, optical insert, or other similar device through
which vision is corrected or modified, or through which eye
physiology is cosmetically enhanced (e.g. iris color) without
impeding vision. Alternatively, Lens may refer to a device that may
be placed on the eye with a function other than vision correction,
such as, for example, monitoring of a constituent of tear fluid or
means of administering an active agent. In some embodiments, the
preferred Lenses of the invention may be soft contact Lenses that
are made from silicone elastomers or hydrogels, which may include,
for example, silicone hydrogels and fluorohydrogels.
[0043] Optic Zone: as used herein refers to an area of an
Ophthalmic Lens through which a wearer of the Ophthalmic Lens
sees.
[0044] Power: as used herein refers to work done or energy
transferred per unit of time.
[0045] Rechargeable or Re-energizable: as used herein refers to a
capability of being restored to a state with higher capacity to do
work. Many uses within this invention may relate to the capability
of being restored with the ability to flow electrical current at a
certain rate for a certain, reestablished time period.
[0046] Reenergize or Recharge: To restore to a state with higher
capacity to do work. Many uses within this invention may relate to
restoring a device to the capability to flow electrical current at
a certain rate for a specified, reestablished time period.
[0047] Released from a Mold: means that a lens is either completely
separated from the mold, or is only loosely attached so that it can
be removed with mild agitation or pushed off with a swab.
[0048] Rigid Insert: as used herein refers to an insert that
maintains a predefined topography. When included in a Contact Lens,
the Rigid Insert may contribute to the functionality of the Lens.
For example, varying topography of or densities within the Rigid
Insert may define zones, which may correct vision in users with
astigmatism.
[0049] Stabilizing Feature: as used herein refers to a physical
characteristic that stabilizes an Ophthalmic Device to a specific
orientation on the eye, when the Ophthalmic Device is placed on the
eye. In some embodiments, the Stabilizing Feature may add
sufficient mass to ballast the Ophthalmic Device. In some
embodiments, the Stabilizing Feature may alter the front curve
surface, wherein the eyelid may catch the Stabilizing Feature and
the user may reorient the Lens by blinking. Such embodiments may be
enhanced by including Stabilizing Features that may add mass. In
some exemplary embodiments, Stabilizing Features may be a separate
material from the encapsulating biocompatible material, may be an
insert formed separately from the molding process, or may be
included in the Rigid Insert or Media Insert.
[0050] Stacked Integrated Component Devices or SIC Devices as used
herein refers to the product of packaging technologies that can
assemble thin layers of substrates, which may contain electrical
and electromechanical devices, into operative integrated devices by
means of stacking at least a portion of each layer upon each other.
The layers may comprise component devices of various types,
materials, shapes, and sizes. Furthermore, the layers may be made
of various device production technologies to fit and assume various
contours.
[0051] Three-dimensional Surface or Three-dimensional Substrate: as
used herein refers to any surface or substrate that has been
three-dimensionally formed where the topography is designed for a
specific purpose, in contrast to a planar surface.
Thermoforming
[0052] In a thermoforming process, a thin sheet of material is
heated to a temperature where it becomes flexible or easily bent.
The sheet of material is then bent or thermoformed to a predefined
shape by a mold piece. By pressing the sheet onto the mold and
typically evacuating the air at the interface of the mold and
sheet, the material is deformed into a three-dimensional shape that
similarly matches the mold piece. Upon cooling, an appropriate thin
sheet material may maintain the three dimensional shape that it has
been formed into.
[0053] Proceeding to FIG. 1, an exemplary apparatus 100 for
thermoforming a sheet may be found. The illustrated apparatus 100
is an exemplary embodiment of an apparatus that may perform
thermoforming, but other alternative embodiments of an apparatus
that performs thermoforming may be consistent with the art herein.
In some embodiments, a sheet 110 of material, which may be
thermoformed, may have holes 111 punched into the sheet 110 so that
the sheet may be fixedly held in place by other portions of the
apparatus.
[0054] The sheet 110 may be held in place by placement between a
top holding piece 120 and a lower holding piece 130. Pins may align
the holes 121 on the top holding piece 120 and the holes 131 on the
lower holding piece 130 with the alignment holes 111 punched into
the sheet 110. Once the sheet 110 is between the top holding piece
120 and the lower holding piece 130, the holding pieces 120 and 130
may be rigidly held together. In some embodiments, a locking
feature such as, for example, a screw, may feed through a hole 121
in the top holding piece 120 at a location external to the thin
sheet 110. For example, a screw may feed into a threaded hole 132
to fixedly hold the sheet 110 in place. In other embodiments, the
thermoforming equipment may hold the sheet 110 in place without the
use of screws or locking feature.
[0055] The held and aligned sheet 110 may be processed using
numerous types of equipment that may utilize alignment holes 122
and 132 for the alignment of the held sheet 110. These processes
may occur before or after thermoforming, but in this exemplary
embodiment, the held sheet 110 may be processed for the step of
thermoforming. In such embodiments, a pin that protrudes through
the lower holding piece 130 may locate the alignment features 122
and 132. The pin may extend above the lower holding piece 130 to
align the sheet 110 and the top holding piece 120 and below the
lower piece 130 to align the sheet with the molding features of the
thermoforming apparatus 140. The pins below the lower holding piece
130 may mate in an aligned fashion to alignment holes 141 on the
thermoforming apparatus 140.
[0056] In some embodiments, the molding apparatus 100 and the thin
sheet 110 may be warmed to an appropriate temperature to make the
sheet pliable, and then pressure may be applied to push the thin
sheet 110 that is held between the top holding piece 120 and the
lower holding piece 130 onto a molding piece 150. As pressure is
applied, a vacuum may be drawn near or at the surface of the
molding piece 150 through the molding apparatus 100 through
connection points 142 and 143. In some embodiments, the temperature
may be controlled at the molding piece 150. In alternate
embodiments, a temperature-controlled fluid may be flowed through
the molding apparatus 100 through connection points 142 and 143. In
still other embodiments, a power source, such as an electrical
current, may heat the forming mold through connection points 142
and 143. In other embodiments, the entire environment of the sheet
110 and thermoforming apparatus 140 may be held at an appropriate
temperature for thermoforming of the thin sheet 110 material.
[0057] When the pressure and vacuum are removed from holding the
thin sheet 110 onto the molding piece 150, the sheet 110 may be
pulled clear of the molding piece 150. When the sheet 110 cools, it
may reassume rigidity in the three-dimensionally formed shape
imparted to the sheet 110 by the thermoforming molding process.
[0058] Proceeding to FIG. 2, an exemplary progression 200 of a
sheet processed to form an insert piece that may then be
thermoformed is illustrated. This progression 200 is for exemplary
purposes only, and other modifications and sequences are within the
scope of this invention.
[0059] The progression 200 may begin at step 210 wherein a thin
sheet 211 of thermoformable material may be provided. In some
embodiments, for example, the thin sheet 211 may be comprised of
polycarbonate. Further examples of thin sheet thermoforming
material are included in Table 1. In some embodiments, at step 220,
the sheet 211 may be processed to have alignment marks placed on it
221. For example, said alignment marks 221 may be printed upon the
sheet 211, punched into the sheet 211, or cut out from the sheet
211. Some embodiments may include holes 222 that are punched into
the sheet 211 to facilitate the holding of the sheet 211 in a
thermoforming apparatus 100, such as, for example, in FIG. 1.
[0060] In some embodiments, at step 230, conductive traces 231 may
be formed upon the sheet 211. These traces 231 may be formed by
coating the sheet 211 with films of conductive material followed by
patterned removal of regions of the conductive material to form
traces 231. In alternate embodiments, the traces 231 may be printed
upon the surface with conductive inks. Any method of forming
conductive traces 231 upon a flat sheet may be consistent with the
art herein.
[0061] In some embodiments, at step 240, the conductive traces 231
may be coated at least in part by an insulating material. A
deposition of insulator may be important for some specific methods
of manufacture, such as, for example, the formation of inserts for
meniscus lens embodiments. In some embodiments, at step 250,
regions of the insert piece may be coated with a film to alter the
hydrophobicity of the surface. In the exemplary embodiment, at step
250, the entire sheet 211 may be coated, but embodiments that coat
only a portion of the sheet 211, such as, for example, only the
region that will become the insert piece, are also within the scope
of this invention. Step 250 may be consistent with embodiments
related to the formation of meniscus type active lenses. At step
260, the thin sheet 211 may be processed with a thermoforming step
creating a three-dimensional shape 261 to the surface of the thin
film material.
[0062] In some embodiments, after 260, the thermoformed sheet 211
may subsequently be processed to create isolated insert pieces. At
step 270, a roughly circular-shaped insert piece may be formed by
cutting out a specified portion 271 of the thermoformed sheet. The
method of cutting may include, for example, mechanical shearing,
punching, or cutting with energized beams, such as laser cutting,
plasma cutting, chemical reaction cutting, or high pressure fluid
jet cutting.
[0063] The next step may depend on the preferred resulting insert
piece embodiment. At step 280, the insert piece may be removed from
the sheet 211 with a central optic portion. In alternative
embodiments, at step 290, the insert piece may be removed from the
sheet 211 where the central optic portion 291 may also be removed
creating an annular insert piece. In this exemplary embodiment, the
thermoformed sheet 211 progresses from step 270 to either step 280
or step 290. In other embodiments, step 280 may be an intermediate
step between step 270 and step 290. Other combinations and
variations of this progression may be apparent to those ordinarily
skilled in the art and are considered within the scope of the art
herein. Utilizing the techniques as have been discussed, more
complicated insert pieces may be formed.
TABLE-US-00001 TABLE 1 Exemplary Thermoforming Materials Film Type
Acrylonitrile Butadiene Styrene Polycarbonate Polystyrene Polyvinyl
Chloride Biaxially oriented polypropylene Polyethylene
terephthalate (PET) Amorphous PET PET-glycol Orientated PET
Biaxially oriented polypropylene Cyclic Olefin Copolymer
[0064] Proceeding to FIG. 3, an ophthalmic insert 300 from a
thermoformed sheet is illustrated. In some embodiments, the
ophthalmic insert 300 may include numerous important features that
result from thermoforming a sheet into a three-dimensional piece.
For example, in some embodiments, the optic zone 310 of an
Ophthalmic Device formed with the insert 300 may include an
optically clear feature. In such embodiments, various material
choices and thermoforming equipment settings may address the
optical clarity of a thermoformed surface.
[0065] Conductive traces 320, 330, 340, 370, and 380 may be added
to the thin film surface before thermoforming or to the three
dimensional shape after thermoforming. In some embodiments, the
surface may include one or both of isolated conductive traces 340
and 370 or electrically connected traces 330 and 380 with a
connection point at 320. The placement of the traces 320, 330, 340,
370, and 380 on the ophthalmic insert 300 is for exemplary purposes
only, and other configurations may be appropriate in some
alternative embodiments. The arrangement may be useful in forming
an energized insert with two electrochemical battery cells
connected in a series fashion. The resulting energization element
may have connection points 350 and 360. Components capable of
drawing an electrical current from an energization element may be
attached, for example, to the connection points 350 and 360 or, in
other embodiments, other locations on the depicted ophthalmic
insert embodiment.
Alignment Aspects of Thermoformed Inserts
[0066] For complex insert components including three-dimensional
shapes, conductive traces, and other components attached or
integrated to the three-dimensionally shaped inserts, the location
of the features and the three-dimensional shapes both relatively
and globally to other Ophthalmic Lens aspects may be significant.
Alignment features on the insert piece may be useful in precision
placement of the components. There may be various designs
consistent with alignment needs including crosses, verniers, lines,
and similar such features. The equipment that processes the thin
film substrate may utilize these features to move the sheet and
attached or holding hardware to an internal alignment location
within its operating space. In some embodiments, the alignment
feature may be a portion of the thin film substrate that may be cut
away during processing.
[0067] Proceeding to FIG. 4, strategies or features that may create
secondary alignment features during the processing to cut out the
insert piece are illustrated. A thermoformed, three dimensionally
shaped insert piece 400 that has been cut out from the thin sheet
may have notches 401 and 402 cut out. Different embodiments may
include notches of varying shape including, for example, a v-shaped
notch, a circular-shaped notch, and a square-shaped notch. Notches
401 and 402 may be located in various locations on the insert piece
400, including, for example, at antipodal locations. The notches
401 and 402 may serve a variety of alignment functions. For
example, the notches 401 and 402 may provide the rotational
alignment of the piece, whereas, in some other embodiments,
alignment features 401 and 402 on the insert piece 400 may create
the alignment in the translational axes of the paper.
[0068] In other embodiments, the insert piece 450 may have grooves
451 and 452. These grooves 451 and 452, or in some embodiments cut
outs, may function similarly to the notches 401 and 402, wherein
the grooves 451 and 452 assist in alignment during the process of
removing the insert piece 450 from a thin sheet, as shown in FIG.
2. In some embodiments, particularly where the insert is comprised
of multiple pieces, grooves 451 and 452 may provide a locking
function. Said embodiments may include another insert piece, not
shown, with protrusions that may fit into the grooves 451 and
452.
[0069] In some embodiments of an insert piece 480, there may be
more than one alignment features or notches. For example, some
insert pieces 480 may have notches 481 and 482 for an apparatus to
place the piece with precision and may include grooves 483 and 484
to ensure proper alignment with another piece. The insert pieces
may also include flat features that act similarly to the notches by
preventing unwanted rotation of the insert piece.
[0070] There may be numerous manners that processing equipment may
utilize notches of the type depicted. For example, a working
surface of a piece of equipment may have alignment pins temporarily
or permanently located on a surface. By moving the insert piece
such that its notches locate upon the pins, the insert piece may be
simultaneously held in place and located in the translational
plane. The rotational orientation in such an embodiment may be
limited to two acceptable rotational orientations that are 180
degrees apart. Alternatively, a three-dimensionally formed insert
piece may inherently be limited in orientations, necessitating
fewer alignment features for precise placement.
[0071] Proceeding to FIG. 5, an embodiment of an Ophthalmic Lens
500 with a thermoformed Rigid Insert 570 is illustrated. In some
embodiments, a three-dimensionally formed insert piece 520 may form
a front insert piece of a Rigid Insert 570, and a second
three-dimensionally formed insert piece 550 may form a back insert
piece of a Rigid Insert 570. The front insert piece 520 may have
alignment features 521 and 522 that fit with the alignment features
551 and 552 of the back insert piece 550.
[0072] In a cross-sectional view, the front insert piece 530 may be
combined with the back insert piece 560 to form a Rigid Insert 570.
The insert pieces 530 and 560 may be three-dimensionally formed to
create a sealed portion. In some embodiments, for example, the
sealed portion may contain a liquid meniscus in electrical
communication with energization elements, which may allow for a
variable optic. The Rigid Insert 570 may be encapsulated in an
Ophthalmic Lens 500. In some embodiments, the encapsulant 501 may
be a biocompatible polymerized material such as a silicone
hydrogel, including, for example, Etafilcon, Narafilcon,
Galyfilcon, and Senofilcon.
[0073] The alignment features 521, 522, 551, and 552 may allow the
two insert pieces 520 and 550 to lock into place without direct
force to the Optic Zone portion or the component. This may allow
for more delicate, but precise, assembly of a Rigid Insert 570. For
example, a liquid meniscus may be susceptible to damage caused by
pressure or heat. In some embodiments, the front piece insert 520
may be locked into the back piece insert 550, and the locking
between the alignment features 521, 522, 551, and 552 may maintain
the positions of the two pieces 520 and 550. The Rigid Insert 570
may be further secured by applying focused pressure or heat to more
robust portions of the insert 570.
[0074] Rigid Inserts may also be useful for embodiments with
annular shapes. There may be numerous uses for annular inserts in
Ophthalmic Lenses including embodiments that may sense the
ophthalmic environment that the lens sits in, such as a means for
glucose monitoring. Rigid Inserts may also include a printed
patterns or Stabilizing Features in the non-Optic Zone portion.
[0075] In such embodiments, an active meniscus-based lens may be
contained within the insert. For example, the Optic Zone may
contain at least two immiscible fluids that form an interface
between them that may act as a focal element. Various energization
elements may be included in regions outside the Optic Zone of the
insert. The energization elements may include, for example,
integrated circuits, passive electronic components, energization
elements, and activation elements that may control the nature of
the meniscus based lens.
[0076] Proceeding to FIG. 6, an exemplary front insert piece 610
and back insert piece 630 are illustrated with the Media Insert 660
that may result in the combination of the two pieces 610 and 630.
The front insert piece 610 may be thermoformed to include recesses
611 and 612 as alignment features for energization elements 662 and
a controlling load 661 in the Media Insert 660. Said recesses 611
and 612 may provide additional protection of the electrical
components 661 and 662 within the Media Insert 660. The back insert
piece 630 may contain guidelines 633 for the conductive traces 663
that may interconnect the electrical components 661 and 662.
Alternatively, in some embodiments, the conductive traces 663 may
be directly applied during the thermoforming process, before or
after the insert piece 630 has been removed from the surrounding
sheet, as in FIG. 2.
[0077] In some embodiments, the Media Insert 660 may be included in
an Ophthalmic Device 680, which may comprise a polymeric
biocompatible material. The Ophthalmic Device 680 may include a
rigid center, soft skirt design wherein a central rigid optical
element comprises the Media Insert 660. In some specific
embodiments, the Media Insert 660 may be in direct contact with the
atmosphere and the corneal surface on respective anterior and
posterior surfaces, or alternatively, the Media Insert 660 may be
encapsulated in the Ophthalmic Device 680. The periphery or
encapsulant 681 of the Ophthalmic Lens 680 may be a soft skirt
material, including, for example, a hydrogel material.
[0078] Proceeding to FIG. 7, an alternate embodiment of an
Ophthalmic Lens 700 with a Rigid Insert 770 is illustrated. In some
embodiments, the front insert piece 720 may be a different size
than the back insert piece 750. Said embodiments also allow for
thermoformed alignment features 721, 722, 751, and 752, wherein
alignment features 721 and 722 on the front insert piece 720 may
fit to the alignment features 751 and 752 on the back insert piece
750.
[0079] In a cross-sectional view, the Rigid Insert 770 may be
three-dimensionally formed to allow for a passive optical function,
such as, for example, a lenslet 771. A lenslet 771 may be located
at the center of the Optic Zone of an Ophthalmic Lens 700. In this
exemplary embodiment, the lenslet 771 is a concave device that may
be filled with a material in a gaseous, liquid or solid state
(including gelled solids) where the index of refraction may be
different from the surrounding Ophthalmic Lens material 701. In
some embodiments, the lenslet 771 may provide a focal altering
characteristic. For example, the lenslet 771 may provide focusing
and magnification of an object located relatively close to the
Ophthalmic Lens.
[0080] In forming the Rigid Insert 770, there may be numerous
considerations for the processing. The lenslet 771 in some
embodiments may be filled with a gaseous material. Since the
pressure in the lenslet 771 may change with the temperature of
processing and the temperature of use, it may be important to
control the temperature of all processing steps after the multiple
pieces are assembled and sealed into an insert. For example,
maintaining the temperature around a set point of roughly 35
degrees Celsius in some embodiments may mitigate changes caused by
filling the insert with liquids and or gelled or partially gelled
solids with different index of refraction from either or both the
thermoforming film material and Ophthalmic Lens encapsulating
material. Alternatively, the lenslet 771 may hold an encapsulated
lenslet material 772. In some embodiments, the lenslet material 772
may be coated, with parylene, for example, to isolate the lenslet
material 772 from the surrounding material.
Functional Aspects of Thermoformed Inserts
[0081] Proceeding to FIG. 8, examples of embodiments where
thermoforming may add functionality to the insert piece are
illustrated. An insert piece 800 may provide a means to deliver an
active agent, such as medicine. Guidelines 801-803 may be
thermoformed on the insert piece 800, or in some embodiments, the
active agent may directly applied during thermoforming. Adding an
active agent to an insert piece 800 may allow for controlled
administering of a drug to the body through the eye.
[0082] In some embodiments, an insert piece 800 may be an annular
shape with a central circular shape, which may have its center
collocated with the external approximately circular shape removed.
An annular shape may be appropriate where the function of the
Ophthalmic Lens with an insert piece 800 may not be related to
optical properties, such as, for example, where the purpose is to
passively administer an active agent deposited on guidelines
801-803. The material removed from the internal regions may in
practice assume a great diversity of shapes and also involve the
nature of the three-dimensional features that may be thermoformed
into the film. For example, the cutting process may remove those
features with a height of deformation above a certain level.
[0083] In some embodiments, thermoforming may add colored design to
the insert piece 820, which may give an Ophthalmic Lens a cosmetic
function. The pattern 821 may have been applied before or after
thermoforming and may be located on one or both of the major
surfaces of a thermoformed insert. A printed pattern 821 may be
located outside of the Optic Zone of the Ophthalmic Lens.
Therefore, a printed pattern 821 may be included in embodiments
where the Ophthalmic Lens has functions in addition to a cosmetic
feature. For example, a printed pattern 821 may be included on a
multi-piece Rigid Insert 570, such as shown in FIG. 5. In
alternative embodiments, a printed pattern 821 may be included in
annular insert pieces, such as, for example, where the function of
the Ophthalmic Lens or the function of the Rigid Insert is not
related to an optical quality. In some specific embodiments, a
printed pattern 821 may be included in insert pieces 800 to mask
active agent guidelines 801-803.
[0084] Alternatively, polarization features 851 may be thermoformed
onto an insert piece 850. In some embodiments, such features 851
may be imparted to insert pieces 850 through properties of thin
film starting materials. The innate polarizing properties of the
starting material may be enhanced by thermoforming additional
polarization features 851. Alternatively, the thermoforming process
may be sufficient to impart the polarization features 851. The
inclusion of polarizing features 851 to an insert piece 850 may add
functionality in some embodiments that may contain passive,
nonenergized inserts.
[0085] There are four major techniques for polarizing light through
a transmissible material including wire grids, dichroic materials
as is commonly employed in "polaroid filters", employment of
Brewster's angles plates, and employment of birefringent or biaxial
materials. The polarization function may be developed in an
Ophthalmic Lens through a single technique or by a combination of
techniques. For example, in some embodiments, the polarizing
features 851 of an insert piece 850 may include wire grids and
dichroic materials.
[0086] In some embodiments, the structure of the insert itself or
layers placed upon the insert piece may polarize light that
transmits through the ophthalmic insert optic zone. For example,
the thermoforming thin film material that is used to form the
insert may be constructed in a multilayer fashion, such as by
stacking layers to form the structural function of the insert piece
850 and to polarize light. In some embodiments, the sheet of
material from which the insert piece 850 is removed may be a sheet
of thin metallic or conductive filaments or lines deployed in a
parallel fashion to form a wire grid.
[0087] Alternatively, a film of dichroic materials may have
polarizing properties imparted to it. Some embodiments may include
layers of films, each contributing to the polarizing features 851.
For example, the top and bottom films may act to protect the
internal polarizing film, and the protecting layers may be
three-dimensionally formed through the thermoforming process. A
polarized insert piece 850 may also have printed patterns 821
included in the portion outside of the Optic Zone.
[0088] In other embodiments, a Rigid Insert may be comprised of
insert pieces with polarizing features that, when layered in the
Rigid Insert, may create a complex polarization element. For
example, the polarizing features may be enhanced by thermoformed
topography of an insert piece.
[0089] Some embodiments may include an insert piece 880 with a
tinting 881 in the Optic Zone. In some embodiments, the color tint
may be an innate property of the thin film material used as a
starting material. In other embodiments, the coloring property may
be added to the thin film material by depositions, applications, or
other means of imparting a color to the thin film surface or bulk.
A color tinting 881 may provide a variety of functions in an
Ophthalmic Lens. For example, the tinting 881 may be useful in
excluding or attenuating wavelengths of light as may be the
function of shading ambient sunlight.
[0090] Alternatively, information may be displayed in different
wavelength regimes, where an Ophthalmic Lens with appropriate
filter aspects may use or exclude the information. The tinting 881
may provide safety functions where the tinting may block certain
wavelengths thereby shielding or partially shielding the effect of
intense radiation sources such as, for example, lasers or welding
arcs. In some embodiments, the tinting 881 may address medical
conditions in some users, who may benefit from either passing or
rejecting certain wavelengths from entering the user's eye.
Numerous filtering or band pass functions may be imparted to
Ophthalmic Lenses by their inclusion into insert pieces 880, and
the process of thermoforming flat sheets of material may enhance
methods and process related to such embodiments.
[0091] Proceeding to FIG. 9, an exemplary embodiment of a left Lens
910 and a right Lens 960 with insert pieces 900 and 950 that have
been thermoformed to include polarization features 901 and 951 is
illustrated. Together, the inserts may act as a set of functional
Ophthalmic Lenses. Polarizing features 901 and 951 may be
incorporated into insert pieces 900 and 950 in the Optic Zone.
Alignment features, such as, for example, those included in the
exemplary embodiments in FIG. 4, may allow for precise control of
the differing polarizing orientations of the right lens 910 and the
left lens 960.
[0092] For example, when the polarizing insert piece 900 and 950 is
assembled into an Ophthalmic Lens 910 and 960, the insert piece 900
and 950 may be positioned with alignment features into a cavity
formed between a front curve Mold and a back curve Mold. The insert
piece 900 and 950 may be encapsulated by filling the area between
the Mold Pieces with Reactive Monomer Mixture and then polymerizing
the RMM. Numerous Reactive Monomer Mixtures may be consistent with
the formation of molded Ophthalmic Devices, including, for example,
those capable of forming hydrogel lenses, such as silicone
hydrogel.
[0093] In some embodiments, during the molding process, the molds
may include capability of forming Stabilizing Features 912, 913,
962, and 963 into the Ophthalmic Devices. These stabilization zones
may be thicker regions of gelled polymer material in the regions
depicted. The gelled polymer material may be added to the Molds
prior to encapsulation, or, in other embodiments, may be injected
into the skirt 911 and 961 after polymerization.
[0094] Alternatively, Stabilizing Features 902, 903, 952, and 953
may be thermoformed into the insert pieces 900 and 950. In some
such embodiments, as seen in cross-section, the Stabilizing
Features 922 and 972 may not affect the surface of the Ophthalmic
Lens 920 and 970. Whereas, in other embodiments, not shown, the
Stabilizing Features may affect the surface topography of the
Ophthalmic Lens.
[0095] Thermoforming allows for more complex three-dimensionally
formed insert pieces, as seen cross section, 921 and 971.
Therefore, the insert piece 921 and 971 may be formed from a single
sheet, as seen in FIG. 2, or, alternatively, the Stabilizing
Features 922 and 972 may be attached after the insert piece 921 and
971 has been removed from the sheet. The attachment may utilize
thermoforming techniques or any other means of attachment, such as,
for example, the use of adhesives.
[0096] The extra mass and, where the Stabilizing Features alter the
surface topography of the Ophthalmic Lens, the interaction of the
Stabilizing Features with a user's eyelids may hold the lenses in a
rotational and translational orientation relative to the user's
eye. Said Stabilizing Features 912, 913, 962, and 963 may allow for
Lenses 910 and 960 that have similar polarizing orientation, such
as, for example, where the Lenses 910 and 960 shield the eye from
reflected sunlight. Alternatively, as shown, a different
orientation of the polarizing elements 901 and 951 may allow for
differential communication of information to each eye, which may
provide numerous functions, including Three-dimensional Perception
of stereoscopic media. As with other embodiments, these types of
embodiments may also include printed patterns in the portion 911
and 961 outside the Optic Zone.
Materials for Insert Based Ophthalmic Lenses
[0097] In some embodiments, a lens type can be a lens that includes
a silicone containing component. A "silicone-containing component"
is one that contains at least one [--Si--O--] unit in a monomer,
macromer, or prepolymer. Preferably, the total Si and attached O
are present in the silicone-containing component in an amount
greater than about 20 weight percent, and more preferably greater
than 30 weight percent of the total molecular weight of the
silicone-containing component. Useful silicone-containing
components preferably comprise polymerizable functional groups such
as acrylate, methacrylate, acrylamide, methacrylamide, vinyl,
N-vinyl lactam, N-vinylamide, and styryl functional groups.
[0098] In some embodiments, the Ophthalmic Lens skirt, which
sometimes may be called an insert encapsulating layer, that
surrounds the insert may be comprised of standard hydrogel lens
formulations. Exemplary materials with characteristics that may
provide an acceptable match to numerous insert materials may
include the Narafilcon family; including Narafilcon A and
Narafilcon B. Alternatively, the Etafilcon family; including
Etafilcon A may represent good exemplary material choices. A more
technically inclusive discussion follows on the nature of materials
consistent with the art herein; but it may be clear that any
material which may form an acceptable enclosure or partial
enclosure of the sealed and encapsulated inserts are consistent and
included.
[0099] Suitable silicone containing components include compounds of
Formula I
##STR00001##
where:
[0100] R.sup.1 is independently selected from monovalent reactive
groups, monovalent alkyl groups, or monovalent aryl groups, any of
the foregoing which may further comprise functionality selected
from hydroxy, amino, oxa, carboxy, alkyl carboxy, alkoxy, amido,
carbamate, carbonate, halogen or combinations thereof; and
monovalent siloxane chains comprising 1-100 Si--O repeat units
which may further comprise functionality selected from alkyl,
hydroxy, amino, oxa, carboxy, alkyl carboxy, alkoxy, amido,
carbamate, halogen or combinations thereof;
[0101] where b=0 to 500, where it is understood that when b is
other than 0, b is a distribution having a mode equal to a stated
value;
[0102] wherein at least one R.sup.1 comprises a monovalent reactive
group, and in some embodiments between one and 3 R.sup.1 comprise
monovalent reactive groups.
[0103] As used herein "monovalent reactive groups" are groups that
can undergo free radical and/or cationic polymerization.
Non-limiting examples of free radical reactive groups include
(meth)acrylates, styryls, vinyls, vinyl ethers,
C.sub.1-6alkyl(meth)acrylates, (meth)acrylamides,
C.sub.1-6alkyl(meth)acrylamides, N-vinyllactams, N-vinylamides,
C.sub.2-12alkenyls, C.sub.2-12alkenylphenyls,
C.sub.2-12alkenylnaphthyls, C.sub.2-6alkenylphenylC.sub.1-6alkyls,
O-vinylcarbamates and O-vinylcarbonates. Non-limiting examples of
cationic reactive groups include vinyl ethers or epoxide groups and
mixtures thereof. In one embodiment the free radical reactive
groups comprises (meth)acrylate, acryloxy, (meth)acrylamide, and
mixtures thereof.
[0104] Suitable monovalent alkyl and aryl groups include
unsubstituted monovalent C.sub.1 to C.sub.16alkyl groups,
C.sub.6-C.sub.14 aryl groups, such as substituted and unsubstituted
methyl, ethyl, propyl, butyl, 2-hydroxypropyl, propoxypropyl,
polyethyleneoxypropyl, combinations thereof and the like.
[0105] In one embodiment b is zero, one R.sup.1 is a monovalent
reactive group, and at least 3 R.sup.1 are selected from monovalent
alkyl groups having one to 16 carbon atoms, and in another
embodiment from monovalent alkyl groups having one to 6 carbon
atoms. Non-limiting examples of silicone components of this
embodiment include
2-methyl-,2-hydroxy-3-[3-[1,3,3,3-tetramethyl-1-[(trimethylsilyl)oxy]disi-
loxanyl]propoxy]propyl ester ("SiGMA"),
2-hydroxy-3-methacryloxypropyloxypropyl-tris(trimethylsiloxy)silane,
3-methacryloxypropyltris(trimethylsiloxy)silane ("TRIS"),
3-methacryloxypropylbis(trimethylsiloxy)methylsilane and
3-methacryloxypropylpentamethyl disiloxane.
[0106] In another embodiment, b is 2 to 20, 3 to 15 or in some
embodiments 3 to 10; at least one terminal R.sup.1 comprises a
monovalent reactive group and the remaining R.sup.1 are selected
from monovalent alkyl groups having 1 to 16 carbon atoms, and in
another embodiment from monovalent alkyl groups having 1 to 6
carbon atoms. In yet another embodiment, b is 3 to 15, one terminal
R.sup.1 comprises a monovalent reactive group, the other terminal
R.sup.1 comprises a monovalent alkyl group having 1 to 6 carbon
atoms and the remaining R.sup.1 comprise monovalent alkyl group
having 1 to 3 carbon atoms. Non-limiting examples of silicone
components of this embodiment include
(mono-(2-hydroxy-3-methacryloxypropyl)-propyl ether terminated
polydimethylsiloxane (400-1000 MW)) ("OH-mPDMS"),
monomethacryloxypropyl terminated mono-n-butyl terminated
polydimethylsiloxanes (800-1000 MW), ("mPDMS").
[0107] In another embodiment b is 5 to 400 or from 10 to 300, both
terminal R.sup.1 comprise monovalent reactive groups and the
remaining R.sup.1 are independently selected from monovalent alkyl
groups having 1 to 18 carbon atoms which may have ether linkages
between carbon atoms and may further comprise halogen.
[0108] In one embodiment, where a silicone hydrogel lens is
desired, the lens of the present invention will be made from a
Reactive Mixture comprising at least about 20 and preferably
between about 20 and 70% wt silicone containing components based on
total weight of reactive monomer components from which the polymer
is made.
[0109] In another embodiment, one to four R.sup.1 comprises a vinyl
carbonate or carbamate of the formula:
##STR00002##
[0110] wherein: Y denotes O--, S-- or NH--;
R denotes, hydrogen or methyl; and q is 0 or 1.
[0111] The silicone-containing vinyl carbonate or vinyl carbamate
monomers specifically include:
1,3-bis[4-(vinyloxycarbonyloxy)but-1-yl]tetramethyl-disiloxane;
3-(vinyloxycarbonylthio) propyl-[tris(trimethylsiloxy)silane];
3-[tris(trimethylsiloxy)silyl]propyl allyl carbamate;
3-[tris(trimethylsiloxy)silyl]propyl vinyl carbamate;
trimethylsilylethyl vinyl carbonate; trimethylsilylmethyl vinyl
carbonate, and
##STR00003##
[0112] Where biomedical devices with modulus below about 200 are
desired, only one R.sup.1 shall comprise a monovalent reactive
group and no more than two of the remaining R.sup.1 groups will
comprise monovalent siloxane groups.
[0113] Another class of silicone-containing components includes
polyurethane macromers of the following formulae:
Formulae IV-VI
[0114] (*D*A*D*G).sub.a*D*D*E.sup.1;
E(*D*G*D*A).sub.a*D*G*D*E.sup.1 or;
E(*D*A*D*G).sub.a*D*A*D*E.sup.1
wherein:
[0115] D denotes an alkyl diradical, an alkyl cycloalkyl diradical,
a cycloalkyl diradical, an aryl diradical or an alkylaryl diradical
having 6 to 30 carbon atoms,
[0116] G denotes an alkyl diradical, a cycloalkyl diradical, an
alkyl cycloalkyl diradical, an aryl diradical or an alkylaryl
diradical having 1 to 40 carbon atoms and which may contain ether,
thio or amine linkages in the main chain;
[0117] * denotes a urethane or ureido linkage;
[0118] .sub.a is at least 1;
[0119] A denotes a divalent polymeric radical of formula:
##STR00004##
R.sup.11 independently denotes an alkyl or fluoro-substituted alkyl
group having 1 to 10 carbon atoms which may contain ether linkages
between carbon atoms; y is at least 1; and p provides a moiety
weight of 400 to 10,000; each of E and E.sup.1 independently
denotes a polymerizable unsaturated organic radical represented by
formula:
##STR00005##
wherein: R.sup.12 is hydrogen or methyl; R.sup.13 is hydrogen, an
alkyl radical having 1 to 6 carbon atoms, or a --CO--Y--R.sup.15
radical wherein Y is --O--, Y--S-- or --NH--; R.sup.14 is a
divalent radical having 1 to 12 carbon atoms; X denotes --CO-- or
--OCO--; Z denotes --O-- or --NH--; Ar denotes an aromatic radical
having 6 to 30 carbon atoms; w is 0 to 6; x is 0 or 1; y is 0 or 1;
and z is 0 or 1.
[0120] A preferred silicone-containing component is a polyurethane
macromer represented by the following formula:
[0121] Formula IX (the full structure may be understood by joining
corresponding asterisk regions, * to *, ** to **)
##STR00006##
wherein R.sup.16 is a diradical of a diisocyanate after removal of
the isocyanate group, such as the diradical of isophorone
diisocyanate. Another suitable silicone containing macromer is
compound of formula X (in which x+y is a number in the range of 10
to 30) formed by the reaction of fluoroether, hydroxy-terminated
polydimethylsiloxane, isophorone diisocyanate and
isocyanatoethylmethacrylate. Formula X (the full structure may be
understood by joining corresponding asterisk regions, * to *)
##STR00007##
[0122] Other silicone containing components suitable for use in
this invention include macromers containing polysiloxane,
polyalkylene ether, diisocyanate, polyfluorinated hydrocarbon,
polyfluorinated ether and polysaccharide groups; polysiloxanes with
a polar fluorinated graft or side group having a hydrogen atom
attached to a terminal difluoro-substituted carbon atom;
hydrophilic siloxanyl methacrylates containing ether and siloxanyl
linkanges and crosslinkable monomers containing polyether and
polysiloxanyl groups. Any of the foregoing polysiloxanes can also
be used as the silicone-containing component in this invention.
Methods
[0123] The following method steps are provided as examples of
processes that may be implemented according to some aspects of the
present invention. It should be understood that the order in which
the method steps are presented is not meant to be limiting and
other orders may be used to implement the invention. In addition,
not all of the steps are required to implement the present
invention and additional steps may be included in various
embodiments of the present invention.
[0124] Referring now to FIG. 10, item 1000, a flowchart illustrates
exemplary steps that may be used to implement the present
invention. At 1001, a flat substrate typically in the form of a
sheet of material may have alignment features imparted to it. These
features may be stamped or cut out shapes made into the sheet or
deformed regions as a stamp may provide without cutting material.
In other embodiments, an alignment feature may be printed upon the
sheet. In some embodiments, the surface or bulk of the sheet may
have altered coloration by various processes including thermal
treatments. The shapes may include crosses, verniers,
multidirectional lines or the like, which when observed by a
processing tool may allow for the unambiguous translational and
rotational alignment of the piece. In addition, in some
embodiments, holding features that may fixedly lock into place the
substrate during processing may be formed. These features may be
cut out features of various shapes that allow locating pins or
components to feed through the substrate sheet in defined
manners.
[0125] At 1002, in some embodiments, a Rigid Insert may include
electrical traces that may be formed upon the flat substrate in
defined locations relative to the alignment features. The methods
of forming these interconnect features may include, for example,
deposition and patterned etching; direct writing of interconnect
features, such a, with laser-induced chemical vapor deposition;
printing upon the substrate, such as with conductive ink printing;
or pattered by the screened deposition of conductive material. In a
specialized version of the processing, in some embodiments, the
definition of alignment features and the placement of interconnect
features may be performed simultaneously in the same processing
steps.
[0126] At 1003 in some embodiments, dielectric or insulating films
may be formed in selected regions. These may cover and insulate the
traces in the regions of deposition. The dielectric or insulating
films may be deposited in blanket fashion followed by a patterned
etching process, may be printed from an insulating ink material, or
may be regionally deposited by a screened deposition process.
[0127] At 1004 in some embodiments, and particularly in those
embodiments that form an electro-wetting based meniscus lens active
optic element, a film may be regionally applied to alter the
hydrophobicity of the applied substrate and substrate features
surface. The method of application may include techniques as may be
utilized for steps 1002 and 1003.
[0128] At 1005, the thin sheet with any applied films may next be
subjected to a thermoforming process. In many embodiments the
alignment features formed in steps 1001 or 1002 may be used to
align the thin film substrate with the correct location relative to
a mold piece upon which the substrate may be thermoformed into a
desired three dimensional shape. In some embodiments, the
processing may occur for a single molding feature at a time, in
others multiple thermoforming heads may be simultaneous applied to
substrate material to create a number of thermoformed features.
[0129] At 1006, the thermoformed substrate may have insert pieces
cut from it. The alignment features formed at step 1001 or 1002 may
be useful to ensure the correct alignment of the cutting process to
the various aligned features of and on the three dimensionally
formed substrate piece.
[0130] The cutting process may be performed by mechanical sheering,
as may occur with a sharp stamping process or other sheering
process, and may introduce into the singulated or cut-out insert
piece other alignment features to simultaneously register alignment
even if the previous alignment features are removed from the insert
piece by the cutting operation. These new alignment features may
include, for example, notches, slots, rounds, and flats, or various
combinations of these. The resulting insert piece may comprise the
insert in cases of a single piece insert. In multi-piece Rigid
Inserts, at 1007, steps at 1001-1006 may be repeated to form at
least a second insert piece. In such embodiments, at 1007, the
resulting insert piece may be combined with other
three-dimensionally shaped features or with other insert pieces.
When the insert piece is sealed, joined, or connected to the other
three-dimensional insert pieces, together they may form an
ophthalmic insert. In some such embodiments, the step at 1008 may
utilize a thermoforming process, for example, where multiple pieces
are constructed in concert or where the functional features are not
susceptible to thermoforming temperatures.
[0131] At 1008, the resulting ophthalmic insert may be encapsulated
by Ophthalmic Lens-forming materials to form an Ophthalmic Device.
In some embodiments, the Ophthalmic Lens may be formed by placing a
formed insert between two mold parts and by reacting a lens forming
mixture molding the insert piece to be within the Ophthalmic Lens.
The molding process may also occur in multiple steps where a thin
layer of Reactive Mixture may be initially formed on a mold surface
followed by the placement of the insert and fixed by reacting the
Reactive Mixture. The combination of a first Ophthalmic Lens layer
and the insert is then formed with additional Reactive Mixture
between the molds into an Ophthalmic Lens. The various materials
that have been discussed may be used alone or in combination to
form an Ophthalmic Device that includes an embedded insert, which
may include three-dimensional pieces that have been formed by
thermoforming.
[0132] Although the invention may be used to provide inserts
containing hard or soft contact lenses made of any known lens
material, or material suitable for manufacturing such lenses,
preferably, the lenses of the invention are soft contact lenses
having water contents of about 0 to about 90 percent. More
preferably, the lenses are made of monomers containing hydroxy
groups, carboxyl groups, or both or be made from
silicone-containing polymers, such as siloxanes, hydrogels,
silicone hydrogels, and combinations thereof. Material useful for
forming the lenses of the invention may be made by reacting blends
of macromers, monomers, and combinations thereof along with
additives such as polymerization initiators. Suitable materials
include, without limitation, silicone hydrogels made from silicone
macromers and hydrophilic monomers.
CONCLUSION
[0133] The present invention, as described above and as further
defined by the claims below, provides methods for creating
single-piece or multi-piece Rigid Inserts that may be included in
an Ophthalmic Lenses or may comprise the Ophthalmic Lens, wherein
the Rigid Insert may be formed through the processing of thin sheet
material by thermoforming. Single piece annular ophthalmic inserts
may perform the function of providing a template for printed
patterns to be included in Ophthalmic Lenses. Single piece full
ophthalmic inserts may perform the function of polarizing light or
filtering light based on the properties of materials used to form
the insert. The present invention also includes apparatus for
implementing such methods, as well as Ophthalmic Lenses and inserts
formed with the Rigid Insert pieces that have been
thermoformed.
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